Medical device recalls: February 2003
The FDA posted 113 medical device recall records in February 2003, from 45 recall events by 34 companies. 113 have not been classified yet.
Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.
Companies with the most recall events
- Symbiosis Corp. · 4 events, 5 records
- Beckman Coulter Inc · 4 events, 4 records
- Baxter Healthcare Corp. · 2 events, 22 records
- Stryker Howmedica Osteonics · 2 events, 9 records
- Ascension Orthopedics, Inc · 2 events, 2 records
- Ortho-Clinical Diagnostics · 2 events, 2 records
- Philips Medical Systems · 2 events, 2 records
- Cook, Inc. · 1 event, 13 records
FDA root cause
- Other · 107
- Packaging process control · 6
Not yet classified (113)
The FDA has posted these records but has not published a class for them yet.
- Z-0425-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0426-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0427-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0428-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0429-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0430-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0431-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0432-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0433-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0434-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0435-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0436-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0437-03 · Cook, Inc. · posted Feb 28, 2003 · Terminated
The tip of the stiffened cannula might break during use and remain in the patient.
- Z-0593-03 · Jomed Catheters, Inc. · posted Feb 28, 2003 · Terminated
6 Fr. catheters packaged and labeled as 5 Fr.
- Z-0594-03 · Philips Medical Systems, Inc. Cardiac & Monitoring Systems · posted Feb 28, 2003 · Terminated
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- Z-0595-03 · Philips Medical Systems, Inc. Cardiac & Monitoring Systems · posted Feb 28, 2003 · Terminated
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- Z-0596-03 · Philips Medical Systems, Inc. Cardiac & Monitoring Systems · posted Feb 28, 2003 · Terminated
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- Z-0597-03 · Philips Medical Systems, Inc. Cardiac & Monitoring Systems · posted Feb 28, 2003 · Terminated
Central Station Monitoring Information Centers may experience sreeen freeze, i.e. loss of display, keyboard or mouse lock up
- Z-0598-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0599-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0600-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0601-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0602-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0603-03 · C. R.Bard, Inc./Electrophysiology Division · posted Feb 28, 2003 · Terminated
Sterile barrier maybe perforated compromising sterility of the device
- Z-0586-03 · Philips Medical Systems · posted Feb 27, 2003 · Terminated
INTERNAL SHORT CIRCUIT - MAY ALLOW FOR STAND AND TABLE TO MOVE SPONTANEOUSLY IN UPWARD OR DOWNWARD MOVEMENT
- Z-0587-03 · Stryker Howmedica Osteonics · posted Feb 27, 2003 · Terminated
Some components have disassociated post-operatively resulting in additional surgery to the patient.
- Z-0588-03 · Stryker Howmedica Osteonics · posted Feb 27, 2003 · Terminated
Some components have disassociated post-operatively resulting in additional surgery to the patient.
- Z-0589-03 · Symbiosis Corp. · posted Feb 27, 2003 · Terminated
Labeled as J tip but may be straight tip.
- Z-0590-03 · Symbiosis Corp. · posted Feb 27, 2003 · Terminated
Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- Z-0591-03 · Symbiosis Corp. · posted Feb 27, 2003 · Terminated
Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
- Z-0592-03 · Symbiosis Corp. · posted Feb 27, 2003 · Terminated
Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
- Z-0577-03 · Cook Biotech, Inc. · posted Feb 26, 2003 · Terminated
Adverse events- suspected pseudoaneurysm
- Z-0578-03 · Lifecor Inc · posted Feb 26, 2003 · Terminated
Wires may break or pull out, causing device to malfunction
- Z-0579-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0580-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0581-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0582-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0583-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0584-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0585-03 · Stryker Howmedica Osteonics · posted Feb 26, 2003 · Terminated
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Z-0566-03 · Ortho Development Corporation · posted Feb 25, 2003 · Terminated
Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Z-0567-03 · Ortho Development Corporation · posted Feb 25, 2003 · Terminated
Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Z-0568-03 · Ortho Development Corporation · posted Feb 25, 2003 · Terminated
Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Z-0569-03 · Ortho Development Corporation · posted Feb 25, 2003 · Terminated
Cleaning agent residue from packaging material was adhering to implantable hip stems.
- Z-0570-03 · Beckman Coulter Inc · posted Feb 25, 2003 · Terminated
Failure to cycle properly ammong samples.
- Z-0571-03 · Beckman Coulter Inc · posted Feb 25, 2003 · Terminated
Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
- Z-0572-03 · Dynarex Corporation · posted Feb 25, 2003 · Terminated
Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
- Z-0573-03 · Dynarex Corporation · posted Feb 25, 2003 · Terminated
Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
- Z-0574-03 · Invacare Corp · posted Feb 25, 2003 · Terminated
A short circuit within the charger harness may cause heat damage to the units with potential for fire.
- Z-0575-03 · Nobel Biocare USA Inc · posted Feb 25, 2003 · Terminated
Misprinted radiographic template plates. Misprinted labeling.
- Z-0576-03 · Allegiance Healthcare Corp. · posted Feb 25, 2003 · Terminated
The product labeled as sterile had not been through its sterilzation cycle.
- Z-0557-03 · Ortho-Clinical Diagnostics · posted Feb 21, 2003 · Terminated
Cartons labeled 'TDM Performance Verifier I' may contain TDM Performance Verified II.
- Z-0558-03 · Ortho-Clinical Diagnostics · posted Feb 21, 2003 · Terminated
Label printing irregularities on cartons and/or bottles.
- Z-0559-03 · Sulzer Spine-Tech · posted Feb 21, 2003 · Terminated
With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
- Z-0560-03 · Ventana Medical Systems Inc · posted Feb 21, 2003 · Terminated
Inappropriate staining of tissue specimen caused by decreased sensitivity with certian component of antibody cocktail.
- Z-0561-03 · Boston Medical Products, Inc. · posted Feb 21, 2003 · Terminated
Product sterility may be compromised
- Z-0562-03 · Symbiosis Corp. · posted Feb 21, 2003 · Terminated
Product does not have the needle component as part of the jaw assembly.
- Z-0563-03 · Philips Medical Systems Inc · posted Feb 21, 2003 · Terminated
The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.
- Z-0564-03 · Baxter Healthcare Corp. · posted Feb 21, 2003 · Terminated
Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
- Z-0565-03 · Baxter Healthcare Corp. · posted Feb 21, 2003 · Terminated
Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy
- Z-0554-03 · Cook Urological, Inc. · posted Feb 13, 2003 · Terminated
Product is labeled sterile, but was not sterilized.
- Z-0555-03 · Cook Urological, Inc. · posted Feb 13, 2003 · Terminated
Product is labeled sterile, but was not sterilized.
- Z-0556-03 · Thermage · posted Feb 13, 2003 · Terminated
Product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.
- Z-0157-03 · General Electric Med Systems · posted Feb 12, 2003 · Terminated
The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.
- Z-0549-03 · Ascension Orthopedics, Inc · posted Feb 8, 2003 · Terminated
Brochures approved for international distribution only were distributed domestically.
- Z-0550-03 · Ascension Orthopedics, Inc · posted Feb 8, 2003 · Terminated
Literature approved for international distribution only was distributed domestically.
- Z-0551-03 · Boston Scientific Corporation · posted Feb 8, 2003 · Terminated
Breach in sterile barrrier may compromise sterility
- Z-0552-03 · Boston Scientific Corporation · posted Feb 8, 2003 · Terminated
Breach in sterile barrrier may compromise sterility
- Z-0553-03 · Boston Scientific Corporation · posted Feb 8, 2003 · Terminated
Breach in sterile barrrier may compromise sterility
- Z-0504-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0505-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0506-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0507-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0508-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0509-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0510-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y ↗Z-0511-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y ↗Z-0512-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M8527Y ↗Z-0513-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0514-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0515-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0516-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0517-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0518-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0519-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0520-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0521-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0522-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0523-03 · Baxter Healthcare Corp. · posted Feb 6, 2003 · Terminated
The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.
- Z-0547-03 · Steris Corp · posted Feb 6, 2003 · Terminated
The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.
- Z-0548-03 · Zoll Medical Corporation · posted Feb 6, 2003 · Terminated
Defibrillator may fail to function due to false detection of safety fault condition
- Z-0528-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0529-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0530-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0531-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0532-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0533-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0534-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0535-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0536-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0537-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0538-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0539-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0540-03 · Gulden Ophthalmics · posted Feb 5, 2003 · Terminated
lack of sterility assurance
- Z-0541-03 · Beckman Coulter Inc · posted Feb 5, 2003 · Terminated
Biohazard situation exists for users.
- Z-0542-03 · Medtronic Physio Control Corp · posted Feb 5, 2003 · Terminated
Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
- Z-0543-03 · Surgical Specialties Corp · posted Feb 5, 2003 · Terminated
The wrong product in the box.
- Z-0544-03 · Surgical Specialties Corp · posted Feb 5, 2003 · Terminated
The wrong product in the box.
- Z-0545-03 · Beckman Coulter Inc · posted Feb 5, 2003 · Terminated
The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.
- Z-0546-03 · Biomet Inc · posted Feb 5, 2003 · Terminated
There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.
- Z-0524-03 · Stryker Instruments, Instruments Div. · posted Feb 1, 2003 · Terminated
Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.
- Z-0525-03 · LifeNet · posted Feb 1, 2003 · Terminated
Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.
- Z-0526-03 · Philips Medical Systems · posted Feb 1, 2003 · Terminated
The C-bow support can bend and break allowing C-arm to fall from support
Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.